Hospitalization Due to Heart Failure Quantity | Emergency department visit | Office Visits Urgent | Patient need for Diuretics Intravenous | Patient need for Oral Diuretic Therapy Augmentation | Patient need for Inotropic agent Intravenous | Patient need for Intravenous vasodilator | Patient need for Parenteral therapy Heart failure
Item
subject with a history of at least one heart failure (hf) hospitalization (as defined in the european society of cardiology or american college of cardiology/american heart association guidelines), emergency department (ed) visit, or urgent office visit necessitating intravenous (iv) diuretic or augmentation of oral diuretic, iv inotropic, or iv vasodilator or other hf parenteral therapy within 15 days prior to device implant
boolean
C3898876 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0586082 (UMLS CUI [2])
C0028900 (UMLS CUI [3,1])
C0439609 (UMLS CUI [3,2])
C0686904 (UMLS CUI [4,1])
C0012798 (UMLS CUI [4,2])
C1522726 (UMLS CUI [4,3])
C0686904 (UMLS CUI [5,1])
C3898091 (UMLS CUI [5,2])
C0686904 (UMLS CUI [6,1])
C0304509 (UMLS CUI [6,2])
C1522726 (UMLS CUI [6,3])
C0686904 (UMLS CUI [7,1])
C0443081 (UMLS CUI [7,2])
C0686904 (UMLS CUI [8,1])
C0259961 (UMLS CUI [8,2])
C0018801 (UMLS CUI [8,3])
Implantable cardiac monitor Specified
Item
subject has an implanted reveal® xt device (less than 15 days post implant);
boolean
C3879681 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Cardiac ejection fraction
Item
ejection fraction (ef) less than 40 percent
boolean
C0232174 (UMLS CUI [1])
Access to telephone
Item
patient with access to a telephone line
boolean
C1822200 (UMLS CUI [1])
Use of Software Specified | Other Coding
Item
patient or the patient's caregiver is willing and able to use the medtronic carelink®
boolean
C1524063 (UMLS CUI [1,1])
C0037585 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Use of Network Specified
Item
network monitor and to perform the required duties at home or has a family member or assistant perform those duties
boolean
C1524063 (UMLS CUI [1,1])
C1882071 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Age
Item
age greater than 18 years old
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance | Patient Available Follow-up
Item
patient is willing and able to comply with the clinical investigation plan and willing to remain available for follow-up visit, through study closure
boolean
C0525058 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Informed Consent | Informed Consent Patient Representative
Item
patient (or patient's legally authorized representative) is willing and able to sign and date the study informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
New York Heart Association Classification chronic | New York Heart Association Classification Ambulatory
Item
new york heart association (nyha) class iv (chronic or ambulatory)
boolean
C1275491 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2,1])
C1561561 (UMLS CUI [2,2])
Implantable defibrillator Planned | Artificial cardiac pacemaker Planned | Implantable defibrillator Previous | Artificial cardiac pacemaker Previous
Item
planned or previous implant of implantable cardioverter-defibrillator or pacemaker device
boolean
C0162589 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0162589 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0030163 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
Life Expectancy Due to Disease | Exception Cardiovascular Diseases
Item
patient's life expectancy is less than one year due to non cardiovascular disorders, in the opinion of the physician
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007222 (UMLS CUI [2,2])
Severe chronic obstructive pulmonary disease
Item
severe chronic obstructive pulmonary disorder (copd)
boolean
C0730607 (UMLS CUI [1])
Chronic atrial fibrillation
Item
chronic atrial fibrillation at time of enrollment
boolean
C0694539 (UMLS CUI [1])
ST segment elevation ECG
Item
st segment elevation at time of electrocardiogram
boolean
C0520886 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Cognition Disorder
Item
cognitive disease
boolean
C0009241 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Absent
Item
pregnancy or childbearing potential and not on reliable contraceptive
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Poor compliance Anticipated | Study Subject Participation Status | Clinical Trial
Item
anticipated compliance problem or participation in another competitive trial
boolean
C0032646 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
C0008976 (UMLS CUI [3])